Lantheus Holdings, Inc.

Good morning. Welcome to Lanthea's first quarter 2026 conference call. All lines have been placed on mute. This call is being recorded and replay will be available in the investor section of the company's website approximately two hours after the completion of the call and will be archived for at least 30 days. I'll now turn the call over to Mark Canarney, Vice President of Investor Relations. Mark.

Thank you. Good morning. With me today are Mary Ann Haino, our CEO and Executive Chairperson, Amanda Morgan, our Chief Commercial Officer, and Bob Marshall, our CFO. We will begin with prepared remarks and then take your questions. This morning we issued a press release which was furnished to the SEC under Form 8K reporting our first quarter 2026 results. The release and today's slide presentation are available in the Investors section of our website. Any comments could include forward-looking statements, Actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filings. Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the Investors section of our website. I will now turn the call over to Mary Ann.

Thank you, Mark, and good morning, everyone. We had a strong start to the year with solid performance across Polarify, Neuroseek, and DFINITY. These results reflect our ongoing commitment to focus and discipline across the organization. As we said last quarter, 2026 is a year of commercial execution and regulatory milestones. We're making deliberate choices about where we focus our commercial effort and deploying capital so we're positioned to deliver solid results in 2026, and accelerate growth in 2027. Our corporate focus is centered on radio diagnostics, and our priorities for 2026 are clear. First, maintain our market leadership in PSMA PET while preparing for a seamless transition to polarify TrueView, our newly approved PSMA PET formulation, beginning in the fourth quarter. Second, continue to build momentum for Neuroseq through deeper penetration within existing accounts, Leveraging the breadth of the Lanthea's portfolio to unlock incremental growth opportunities and expanding our manufacturing footprint, increasing supply availability. Third, advance our late stage clinical portfolio through key regulatory milestones and ensure launch readiness aligned with coding, coverage, payment, customer preparedness, and market opportunity. And finally, allocate capital with discipline. prioritizing radio diagnostics while evaluating value-maximizing alternatives for our radiotherapeutic assets. In addition to effective commercial execution, we advance several key programs during the quarter that support our long-term growth strategy. On March 6th, the FDA approved Polarify TrueView, our new PSMA PET imaging agent. Polarify TrueView offers the same proven diagnostic properties as Polarify with a similar safety and efficacy profile. The value add of this product will be the larger batch sizes that can be enabled at manufacturing sites with high energy cyclotrons. This creates the potential to serve more patients and support a broader geographic reach. We estimate that more than 70% of Polarify's supply today is produced at PMF sites equipped with high-energy cyclotrons, giving us confidence that, through our broad PMF network, we are well-positioned to optimize the benefit that Polarify TrueView can provide. We also announced during the quarter the FDA extended the PDUFA date for Octavi by three months to June 29, 2026, to allow additional time to review manufacturing-related information. Similar to our efforts with Polarify TrueView, we remain focused on advancing launch readiness, including securing coding, coverage, payment, and customer preparedness through the second half of 2026, with the objective of a full commercial launch in early 2027. On March 2nd, we announced that the FDA had offered tentative approval for PNT-2003, the first radio equivalent to Lutathera. for the treatment of gastroenteropancreatic neuroendocrine tumors, or GPNETs. Tentative approval confirms that the FDA has completed its substantive review and that our application meets the requirements for approval. The timing of our launch will consider the following factors. Timing of final FDA approval, the expiration of the 30-month Hatch-Waxman stay, and disposition of the related legal proceedings, as well as manufacturing and commercial strategy to ensure launch success. As outlined last quarter, our strategy and related investments are centered on radio diagnostics, and the progress we made this quarter reflects that focus. We are selectively prioritizing first and best-in-class pet radio diagnostic assets that complement our existing commercial portfolio and align closely with our nuclear medicine customer base. I will highlight a few key pipeline updates. MK6240, our registrational stage TAU-targeted pet radio diagnostic for Alzheimer's disease, represents an important asset within our pharma solutions portfolio and is the leading imaging agent supporting late-stage Alzheimer's disease-modifying therapy, or DMT, developments. It is currently the most widely used imaging agent in beta amyloid and tau-targeted therapeutic candidate clinical programs. MK6240 serves as an imaging agent for treatment eligibility in 17 current pharma-sponsored AD therapeutic programs and has a PDUFA date of August 13th of this year. Lantheus 2401, our gastrin-releasing peptide receptor, or GRPR, targeted PET radio diagnostic for prostate cancer, is advancing towards its planned registrational program this year. GRPR is a differentiated target from PSMA, and Lantheus 2401 has the potential to complement PSMA PET imaging by identifying disease in patients who may be PSMA negative or equivocal. extending the addressable prostate cancer population while fitting naturally within our existing prostate cancer franchise. Across the pipeline, we remain disciplined in strategically deploying investments based on stage gates and long-term opportunity. With robust mid and long-term revenue drivers, a promising late-stage pipeline, and a clear strategic roadmap, we are confident in our ability to drive meaningful performance gains that support a compelling outlook for our shareholders. and we're executing against that plan. Our strong first quarter results reinforce that 2026 will be a year of commercial execution and regulatory progress, laying the groundwork for growth acceleration beginning in 2027. I also want to provide a brief update on our CEO search. The board's process is progressing well, and we have narrowed the search to a small number of highly qualified candidates. In the meantime, our leadership team and I remain fully focused on execution as the first quarter results fully demonstrate. I will now hand the call over to Amanda to provide additional detail on commercial performance across our oncology, neurology, and cardiology assets.

Thank you, Mary Ann. First quarter performance demonstrated continued commercial execution across our portfolio. with solid volume growth and disciplined performance across each of our three core products. Polarify, our market-leading PSMA PET imaging agent, delivered a solid quarter, with US volume increasing approximately 5.8% year-over-year. Performance was driven by consistent demand across our established customer base and continued pricing discipline in a highly competitive environment. Net ASP and volume for Polarify remain stable sequentially. Despite ongoing competitive activity, we are well positioned as we continue to execute on our portfolio-based strategy. This evolution strengthens our presence across sites of care and our PMF network and reinforces our market leadership and PSMA Pets. Together, these factors support a seamless transition to Polarify TrueView. accelerate neuroses growth, and prepare the organization for future launch opportunities. Overall, Polarify remains a core contributor to our radio diagnostic strategy, supported by disciplined execution, deep customer relationships, and continued usage and expansion of PSMA PET. The FDA approval of Polarify TrueView marks the next chapter of our flagship PSMA PET portfolio. and reinforces our ability to serve the market reliably and at scale. With approval secured, we are now executing against our transition plan, with meaningful revenue contribution expected in 2027. We have submitted our application for a HCPCS code and are preparing to apply for transitional pass-through status. In parallel, we are working closely with our PMF partners to secure necessary FDA approvals for each manufacturing site ahead of the plan conversion. targeted to begin in the fourth quarter of this year. Our approach is deliberate. We will initiate conversions only once reimbursement coding is in place and customers and payer systems are ready to submit and process claims. Our PMS partners are preparing to transition to the new formulation and recognize the operational advantages that Polarify TrueView offers, including enhanced stability at higher radioactive concentrations, which provides greater supply flexibility. This creates the potential to serve more patients within a given market or support delivery to sites that are further from the manufacturing location, or potentially both, depending on demand in a particular area. Now turning to the rest of our commercial portfolios. NeuroSeq, our beta amyloid PET imaging agent for Alzheimer's disease generates $35.4 million in the first quarter revenue. representing 14.3% growth compared to the fourth quarter of 2025. As the second most utilized and fastest growing beta amyloid PET imaging agent in the U.S., NeuroSeq addresses a large and expanding market opportunity. Growth is driven by increased utilization within existing accounts, supported by broader adoption of Alzheimer's, DMTs, and clinical guidelines that favor earlier diagnostic use. particularly in patients with mild cognitive impairment and early Alzheimer's disease. We are leveraging our nuclear medicine relationships across the Lantheus portfolio, supported by continued expansion of our NeuroSeq PMS footprint, which is now up to 22 sites, to drive execution and incremental growth as additional locations come online. Together, these factors further build on the momentum exiting 2025 and reinforce our confidence in NeuroSeq's long-term growth potential. DFIDITY, our market-leading ultrasound enhancing agent, remained a steady contributor to our overall performance and delivered $84.6 million in first quarter revenue, representing year-over-year growth of approximately 6.8%. Growth is primarily driven by increased volume demand. With more than 80% market share, DFINITY continues to demonstrate the durability of a long-standing market preferred product supported by deeply embedded clinical workflows and consistent utilization across sites of care over its 25-year history. I'll now turn the call over to Bob to provide more detail on our first quarter results.

Thank you, Amanda, and good morning, everyone. I will provide highlights of the first quarter of 2026 financials, focusing on adjusted results with comparisons to the prior year quarter, unless otherwise noted. Revenue for the first quarter was $377.3 million, an increase of 1.2 percent compared to the prior year, and increased 8.6 percent when adjusted to exclude 25.2 million of spec revenues from the same period prior year, which was divested on January 1st. Before I begin with the details, I would like to note that we have reconfigured our revenue reporting into new categories to reflect the diversity of our portfolio. The four main groupings include oncology, neurology, cardiology, and strategic partnerships and other, as well as one additional for the invested spec business to reflect prior period results. Our SEC filings reflect this change, and we have grouped prior period comparisons accordingly. Now, starting with oncology, consisting of Polarify, it contributed $240.9 million of revenue, down 6.5% from the prior year. Neurology revenue. consisting of NeuroSeq, was $35.4 million for the quarter. Cardiology revenue, consisting of DFINITY, was $84.6 million, up 6.8% year-over-year. Strategic partnerships and other revenue was $16.3 million, up 52.1%, due to the strength of our pharma solutions portfolio, in addition to adding the evergreen CDMO business. MK6240 represented over half of the revenue in this category. Gross profit margin for the quarter was 67.0%, flat to first quarter 2025, favorably impacted by the spec divestiture, polarify and divinity volumes, as well as divinity price, offset by a decrease in polarify net price and inclusion of the evergreen manufacturing facility and a near-term margin dilution of Neuroseq relative to the company average, both of which were not in the comparative period. Operating expenses at 32.8% of net revenue were 455 basis points unfavorable from the prior period, but favorable to previously guided spending levels. This increase was mainly due to the acquisitions of Evergreen and LMI operations across each spending category, which are not reflected in the prior period. Increases in research and development expense, which was due largely to planned investments to advance our expanded clinical stage portfolio, Sales and marketing increases reflect the inclusion of the Neuroseq sales team and launch activities, mainly focused on Polarify TrueView. G&A was up slightly in the period due to higher professional fees and employee-related costs in the quarter. Operating profit for the quarter was $129.1 million, a decrease of 10.5%. Other income and expense was $0.8 million of expense. Total adjustments in the quarter were $28.1 million of net adjustments before taxes. The company recorded a gain on the sale of SPECT of 59.3 million, an unrecognized gain of 16.6 million attributed to its equity investment in prospective therapeutics, offset by an unrecognized loss of 1.7 million on radiopharm theranostics. Also offsetting these gains, the company incurred 16.0 and 16.7 million of expense associated with non-cash stock and incentive plans and acquired intangible amortization respectively. The company recorded $6.4 million of other acquisition, integration, and divestiture costs. The remaining $7 million is related to other non-recurring expenses. Our effective tax rate was 25.3% in the quarter. The resulting reported net income for the quarter was $118.4 million and a profit of $95.8 million on an adjusted basis, a decrease of 12.5% from the prior year period. GAAP fully diluted earnings per share for the first quarter was $1.80, and $1.46 on an adjusted basis, a decrease of 4.6%. Now turning to cash flow. First quarter operating cash flow totaled $125.1 million as compared to $107.6 million in the prior year quarter. Capital expenditures totaled $3.2 million, $5.5 million less than prior year quarter. Free cash flow, which we defined as operating cash flow less capital expenditures, was $121.9 million, an increase of $23.1 million from the prior year period. Taken together, cash and cash equivalents net of restricted cash were $498.6 million as of the end of Q1. We have $200 million remaining on our board-authorized buyback program and have access to our $750 million undrawn bank revolver. Now, turning to expectations for full year 26. The strong start of the year across the portfolio reinforces our confidence to deliver on the outstanding guidance for both revenue and adjusted EPS. We remain steadfast in our strategies to protect the long-term value of our PSMA franchise, especially ahead of launching Clarify TrueView beginning later this year, and also remain ever mindful of potential competitive dynamics. As such, our full-year forecasted revenue remains at $1.4 to $1.45 billion for 2026. Our first quarter results underscored the disciplined execution of our strategic priorities and commitment to streamlining our cost structure to drive operational efficiencies, enabling us to support sustainable long-term value creation. We are making progress to evaluate alternative opportunities for the therapeutic assets to rebase the company's earnings profile and growth trajectory, as was noted on last earnings call. We continue to balance strategic investments and cost management across the organization and expect to deliver solid bottom line results with EPS in a range of $5 to $5.25. With that, let me turn the call back to Marianne.

Thank you, Bob. In the first quarter, we accomplished what we set out to do. Polarify, Neuroseq, and Affinity all performed well, and we achieved two important regulatory milestones with the FDA approval of Polarify TrueView and tentative approval of P&T 2003. Looking ahead, our priorities are unchanged. Maintain our market leadership in PSMA PET by sustaining Polarify volume growth and executing a seamless transition to Polarify TrueView, continue to build momentum for Neuroseq, and successfully advance our registrational stage products towards regulatory milestones. All of these will position Lantheus for the growth acceleration we expect beginning in 2027. We are driving forward through the rest of 2026 with confidence in our strategy and in the Lantius team's ability to deliver. The first quarter was a terrific start, and we remain focused on the work ahead. With that, I'll turn it over to Q&A. Operator?

Thank you. To ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. In the interest of time, we ask that you limit yourself to one question. Please stand by while we compile the Q&A roster. And our first question comes from Anthony Patrone of Mizuho Financial Group. Your line is open. Anthony, please unmute. One moment for a second. Anthony? Anthony? We'll go to our next question one moment. And our next question comes from Richard Newerter of Truist. Your line is open.

Hi, thanks for taking the questions and congrats on the progress this quarter. I've got, I guess the first one, maybe for Bob on guidance. You know, you had a pretty nice beat um in the first quarter uh across the board at just about every product line i guess um the reiteration of the guide assumes some step down in the 2q to 4q uh presumably uh for for all the all the businesses i i'm assuming that's you know just conservatism uh uh on your part i just wanted to make sure one that's the case and then was there anything is there anything you're seeing that that that would lead you to be incrementally cautious as we move forward into the remainder of the year? Or is this just, you know, good old-fashioned prudence on your part? You still have a few more quarters of transitional pass through disadvantage to get through. And then also, you could just comment on what your assumption is for PSMA PET imaging diagnostics market growth in 2026 for the remainder of the year, and what did it grow in the first quarter? Thank you.

Okay. So, I'll start with the, obviously, with the guidance. So, you know, to your point, we had a very solid start. And, you know, we saw that in terms of volume growth, in terms of pricing dynamics, you know, fairly steady state from what we've seen over the last number of quarters. In fact, you know, almost delivering exactly the same number for each of the last three quarters in a row. But it's early in the year. And so we're going to remain vigilant to market the competitive environment out there. We still have, you know, one competitor who is, you know, Maybe we'll find some footing with their new product, launch themselves, as well as one that will be losing pass-through later this year, call it October 1st. So for us, we're going to, to your point, we're going to be prudent with this. The other thing that I think that plays into this a little bit is the fact that, as Marianne noted in her prepared remarks, that we do see a new CEO in the near future. And I think it's right to allow that person to own the balance of the year. You know, so our assumptions really haven't changed in terms of expecting, you know, what we had said earlier in terms of growth to net as the year progresses. And I still continue to model modest volume growth looking forward. So I wouldn't have you model Q1 forward in that sense. So our strategy remains the same. It's intact. We're watching our competitors and, you know, talking with our customers from many disciplines. And again, the focus for the year is on launching Polarify TrueView and protecting that franchise on a going forward basis.

Hey, Rich, it's Marion, and I'll step in on your second question around the PSMA pet market growth. I think the market continues to play out exactly as we anticipated. If we look back and look back at 25, we saw high teens to low 20s percent growth for the entire market over the course of the year prior, relative to the prior year. And this year, I think we shared in our last quarter's discussion points, we were backing off and saying that we expected for 26 that growth would be in the low teens. And I think that is what we're seeing. I'm not being specific because this is a market that from a data perspective truly has to be triangulated. Unlike the pharmaceutical prescription markets, there are no clean third-party data sources to kind of bring these estimates together. So what we do is we look at our own results. We, of course, monitor what our competitors are reporting. However, as you can imagine, there's not a lot of talk track from Novartis on locumets, and PostLuma is offered by a private company. So I'm offering you that just to say I'm not trying to avoid giving you a direct numeric answer, but it is a triangulated figure that we arrive at, and we're very pleased with what we're seeing in the market.

Thank you. And our next question comes from Anthony Patron from Mizuho Financial Group. Your line is open.

Sorry about that. I was muted hopping across calls here, but congrats on the strong start to the year. Maybe just on TrueView into the TPT ruling and just launch, how that's going to sort of work out from a contracting perspective, When do you think TrueView will be, you know, completely adopted? And at what point does, you know, polarified, you know, Gen 1 get phased out? That would be my question. I'll hop back in queue. Thanks.

Terrific. Good morning, Anthony. Thanks for the question. I'll take that for you. First, let me offer for clarity. It's not a Polarify won't be phased out. Polarify will be transitioned directly to Polarify TrueView. So in any market, only one of the products will be available at a time. And that's very purposeful on our part because, as you can imagine, if our PMS partners had to run two different batches, which they would have to, it would take up too much of their manufacturing time. And we prefer to have a single product in each market that we can focus on. So I wanted to offer that for clarity. It will be geographically a site-by-site conversion. As we've offered before, I'll share again that we plan to begin that conversion in Q4 of this year. It's very carefully thought out, and I'll explain why. These products, as a class, PET diagnostic products are uniformly prior authorized. They require prior authorization for insurance to cover them. We must insure. that insurance coverage is in place and that the systems are fully operational with the coding and the coverage requirements for TrueView before we take that product into any market. In like fashion, and you're aware of this from these comments we've offered, we also have to make sure that we have our HCPCS code and that we have TPT in place, transitional pass-through payment. Those have slightly different schedules of what the application process is for applying and then receiving it. But from our perspective, the one piece that's clear is all must be in place before we ask our customers to start ordering TrueView. We've worked long and hard to make sure that this will be a seamless transition, and we're really confident in it. But that's why you've seen already we got the approval date, but we're not yet in the market. This is carefully thought through and will be exceptionally executed once we take it into the market.

Thank you. And our next question comes from Rowana Ruiz of Learing Partners. Your line is open.

Hey, morning, everyone. I have a follow-up question about TrueView. I was curious, what strategies do you plan to use in terms of enabling customer readiness and prepping hospitals and imaging sites to potentially switch and get really comfortable with TrueView? And I was also curious, given what you've learned from the original Polarify launch, is there anything you want to get ahead of and proactively mitigate in terms of possible hurdles to adoption?

So, Rana, I'll take your question as well, and I'll kind of bounce off of what I just shared from Anthony's question. This is a masterpiece of preparation because before the first dose, and from our customers' perspective, all we want them to see is that their dose shows up and that the coverage and payment, the reimbursement for it has already been fully approved. And so we want it to look invisible to them as to which of the Lantius pet franchise products they're using, TrueView or Polarify. And again, they'll only be using one at a time. There's lots we can do to get ready. And you heard Amanda in Amanda's comments, her repeatedly referring to our prostate cancer franchises. It is actually, in the nuclear medicine customer base, it's actually more than that. We are a full portfolio of products that we bring them in addition to our prostate cancer pet products. And all of our communications with our customers really center on one thing. Do you have the access you need? Does the product show up when you need it? And do you get fair reimbursement and coverage for it? And that is what we work continuously to ensure for our patients. We also will have some work done in order to contractually prepare our customers for TrueView versus Polarify. And that is also something that we're very experienced with. From a nuclear medicine perspective, we have been doing this for 60-plus years with the nuclear medicine department. So we're also confident that we'll be able to handle that. I will say just operationally, there is a set of functional steps that we'll go through with each PMS to ensure that they can manufacture and that they're approved to manufacture. As we've shared in the past, PMS as a network and as an individual site are individually approved as GMP manufacturing sites by the FDA. So we also have a very carefully thought through plan as to how to secure region by region to ensure that the FDA approvals are in place for all of our PMS sites. And as with any other manufacturing site, there's a set of steps you go through with what's called validation batches, which kind of proves out the manufacturing process and that you can consistently replicate that process. Let's remember, Polarify was a first. We, not only in PSMA-PET, but in the scale of a new launch that had not been seen in many decades in a PMS network. We did it then. We're very confident we can do it again with Polarify TrueView.

Thank you. And our next question comes from Matt Taylor of Jefferies. Your line is open.

Hi. Thanks for taking the question. On TrueView, I was wondering if you could talk a little bit about the pricing strategy with TPT and how much in the initial transition period can you realize and can you give any high-level thoughts on how that could impact 2027?

So, Matt, it's Mary, and good morning. Thanks for your question. I will share what I always share. We don't talk about pricing strategy. What I will say and what I think all of you from working so closely with us over the years are aware of is that transitional pass-through is a reimbursement mechanism that's available only in the hospital outpatient setting and only applies to traditional fee-for-service Medicare patients. And so we're very cognizant of how to ensure that the possibility and the opportunity of that coverage being available for that patient group is something that our customers are very aware of. And I don't think I need to say that it's certainly from our learnings with Polarify. It's something we're very focused on to ensure that that reimbursement status is clear and available to all of our hospital-based customers, especially those who have larger patient populations of traditional fee-for-service Medicare. We will not give forward guidance, obviously, to 2027 yet. You'll have to wait later in the year for that, Matt. But as we've said repeatedly throughout our script, we do see 2027 as a year of growth acceleration. So you can probably infer from that. Thank you.

And our next question comes from Yuan Xi of B. Riley. Your line is open.

Good morning. Maybe a question to Marianne or Amanda. On your radar, do you see any other F-18 or Gallium-68 PSMA imaging agent entering the market in the next couple of months? And which market or geographic areas do you anticipate some meaningful impact? Thank you.

You're welcome. I'm going to let Amanda take that for you.

Sure. Thanks for the question. So as you can probably imagine, we continuously monitor the marketplace and we're watching for all types of agents that could enter the market. We remain steadfast on the franchise that we have set up through our prostate cancer franchise and Polarify and the follow-on asset of Polarify TrueView. So we will continue to monitor the marketplace, but we remain steadfast confident in the franchise that we've established, and we remain confident in the relationships that we have with our entire portfolio, as well as within our nuclear medicine relationships.

So, and I'll just add there, I think as anyone who follows this space is aware, we follow. There are two copper-based products that are in development. late stage that have the potential to enter the market at some point in the future. We don't see any of that occurring in 2026, but we continue to follow their progress and their programs. We're also aware that there are two other gallium-based products worldwide, PSMA gallium-based products, that could then have potential for application into the United States. But again, we don't see those as imminent on our highline needs. We have purposely developed a portfolio approach to our nuclear medicine customer base. We feel that that will keep us highly competitive and successful in our interactions with not only our prostate cancer franchise, but our neurology franchise and any other therapeutic areas that we enter with that customer base.

Thank you. And our next question comes from Paul Choi of Goldman Sachs. Your line is open.

Paul, please unmute.

Paul, please unmute. We'll move to our next question. And our next question comes from Andy Shea of William Blair. Your line is open.

Oh, great. Thanks for taking our question. Maybe just kind of an educational one for us. Mary, you mentioned about the high energy cyclotrons that's required for TrueView. So can you give us a sense of what percentage of your PF network is equipped with such equipment? And do you foresee longer term all of them will be transitioned to the high-energy versions. And just maybe comment, as you go through the hardware transition, any sort of supply, maximum supply versus what you expected for the original Polarify? Just kind of get a sense of the ramp-up and also from a production perspective. Thank you.

Sure, and it's a great question. I did address a little bit of this in my remarks, but when we look out at what the current PNF network is that services Polarify and will serve as Polarify TrueView in the future, we estimate that already 70% of that, and I'll call it a fleet, it's a fleet of manufacturing sites, We estimate that 70% of our fleet is already serviced by high-energy cyclotrons, and therefore that gives us confidence that what we see as the value-add of Polarify TrueView is directly transferable into the market. I do want to address operationally something you mentioned about transition of hardware to Polarify TrueView. If you understand the operational basis of a PMF, they essentially use a cyclotron to produce isotopes, and their predominant isotope is obviously F18. But then F18 then is run through a manufacturing process that's called a synthesis box. And it is on the synthesis box that the product-specific elements are added in to form the final product. And so it is a different set, and they call them trace, you know, this is, synthesis boxes have different names, but for all intents and purposes, they call the objects cassettes that they attach to the synthesis boxes to complete the final production of the F18 labeled isotope imaging agent. In this case, they will use a different set of cassettes to produce Polarified TrueView compared to what they were using for Polarified, and compared to the other types of cassettes they used to produce other F18-based isotopes like SDG or the other isotopes that they're producing. To the other part of your question, I'll say that the incredible success of PSMA PET imaging agents, as well now as the emerging building success of pet-based Alzheimer's disease agents has incredibly invigorated the PNF network chains that service the United States medical market. And it's a clear opportunity to them and for them to invest in their operational readiness with higher energy cyclotrons. I can't speak to what their capital plans are for investment are, but I can speak to what has clearly been a renaissance of PMS-based products in the United States and what that means for their business case. Again, just to reiterate to you the first part of your question, The PMS that produced Polarify, 70% of our dose volume currently comes from PMS that have high energy cyclotrons in place. I hope that was clear and helpful. Thank you.

And our next question comes from Paul Toy of Goldman Sachs. Your line is open.

Hi. Thank you, and apologies for fumbling the question earlier. My question is on gross margins, which looked better this quarter than it has in a little while. And this is ahead of your potential switch to TrueView down the line and getting to scale. So my question is, is this sort of a more normalized run rate or is this sort of a one-off for this quarter as we think about sort of the margin profile over the short to intermediate term? Thank you very much.

Paul, appreciate the question. You know, when we gave guidance, I don't know, back when it was in February, I think it's been noted that we would be between sort of 65 and 66%. You know, we're probably going to end up trailing toward the higher end of that particular range. So, there is a little bit of a one-off, and we did have a lot of benefit, you know, coming from, you know, Polarify. and DFINITY volumes. We had, you know, the spec divestiture, which is the majority of the year-over-year change, but that was offset by, you know, the polarity pricing headwind, and as well as, you know, the inclusion of LMI and Evergreen into that into the mix. So, you know, that was intentional. That was, you know, for the spec divestiture in the sense that that gives us sort of the tailwind to offset the clarified pricing headwinds that we see. So, I would still have you model more like where I had guided, but maybe toward the higher end of the range.

Thank you. And as a reminder, if you have a question, please press star 11. And our next question comes from Justin Walsh of Jones Trading. Your line is open.

Hi, thanks for taking the question. I'm wondering if you can comment on the process for turning P&T 2003's tentative approval into a potential full approval in June. And I'm wondering if you can remind us if P&T 2003 is included in the current guidance.

I'll start with your question about approval and then Bob can speak to what he has included in the guidance or not. As I mentioned in my comments, PNT2003 did receive tentative approval in March from the FDA. And for them having offered tentative approval, what they convey with that is that essentially their review is complete and they find the basis of approval for the product. However, because there is a Hatch-Waxman stay with this product, The final approval will require, let's call it three different things. The first is either the expiration of or the resolution of the Hatch-Waxman stay. And what that means is that it's essentially a challenge about whether the original product's patents are being violated by your application. And to the extent that if it's not, you can either have one of two things happen. The 30-month period can expire or the FDA can rule ahead of that, that they be finding that there is no infringement for the products. There's also then related to that, there is the disposition of kind of related legal proceedings, which again, is more of a legal issue. And we will, of course, wait for that. There was the citizen's petition also filed by Novartis and their request for reconsideration of that citizen's position, that was a 150-day period from when it was first filed. So all of that together, I think what we're saying and what we're trying to communicate is that once we have final approval from the FDA, we can technically launch the product. And we see that occurring, again, either at either the expiration of the Hatchman Wax period or the resolution of it, and then the related legal findings. Having said that, what I would also like to communicate is our decision on ultimate launch date will follow the comments you heard me say repeatedly throughout my remarks, and that is we will ensure that there is launch readiness, customer preparedness, and that all coding and coding and reimbursement related benefits are in place for the product before we take it to market.

And with regard to what's in the guidance, I think we had said at the beginning of the year that any of the approvals that we would be getting for products this year were not considered and should not be sort of in any material way embedded into the 2026 total revenue expectation. you know, it's not in the model effectively.

Thank you. And our next question is a follow-up from Matt Taylor from Jefferies. Your line is open.

Hi. Thanks for taking the follow-up. I just had a follow-up on guidance. So I wanted to ask, because of the strong start with Polarify, when you guided before, you were talking about potential for pricing pressure and baking in some conservatism. I guess I just wanted to confirm, it doesn't seem like you're seeing that, are you? And I guess it sounds like you're being conservative with a new CEO coming in. That makes sense. But would you have raised guidance if not for that?

You know what, Matt? I'm going to give Bob a break on this one and answer your question, which I think in large part, Matt, you may have answered for yourself with the way you phrased it. We're early in the year. We're really happy with our first quarter results, but we're also sitting pretty much right in front of a CEO change, which I've also been fairly transparent about. And I think for all of those reasons, we felt that the most prudent thing we could do was hang with the guidance that we had already offered, which we felt was already a great outlook for our company.

Thank you. And our next question is a follow-up from Anthony Patron of Mizuho Financial Group. Your line is open.

Hopping back and forth, but wanted to press again on Neurosec for a moment. Maybe just to reset on Neurosec and the landscape there for beta amyloid tests. And where is the Neurosec share today relative to competitors? I think GE is out there with Visimal and Lilly has AmiVid. What is the expectation for a higher attach rate to the two disease-modifying agents going forward? And, you know, the prescription trends for Alzheimer's disease look bullish. Just an update on that market as we look into the back end of the year. Thanks.

So, Anthony, I'll start with this, and then Amanda can jump in if I miss anything. But I think what you've heard us repeat before, Now, you know, consistently, is Neuroseq holds two places of note in the beta amyloid imaging market. It is the fastest agent growing of the three agents that are currently present in the market. And second, it holds the second highest share already in that market. Now, I'm not going to offer specific market share, again, for the reason that these are estimated figures. We have to triangulate back into them. And I don't think it's germane. I think what's germane to hear from us is that we are investing in Norris Eats. to ensure that it has expanded availability, and availability is key in this market as it is in the other pet tracer markets. That is our major investment thesis for 2026, that we can accomplish two things. Actually, I'll take it even out to a third thing. First, we can use our portfolio approach to have our customers use Neuroseq as their beta amyloid imaging agent of choice based on their relationship with Lantheus and the customer service we provide. Second, that we can drive deeper penetration in existing Neuroseq accounts that goes along with the great growth we're seeing in the market because of, as you referenced, the adoption of and the continued adoption of the beta amyloid therapeutic agents. And third, that we can expand the footprint of where the product is manufactured so that, again, it serves number two, which is deepening penetration in existing accounts, but it also gives us access to new accounts out there. And these are all benefits that we had considered as we considered the LMI acquisition, because as a company at their size and their financial capabilities before the acquisition, they just did not have the bandwidth to take on some of these opportunities. We do, and we will, and we see that coming back to us not only in 26 already, but certainly in 27 and beyond. Amanda, did I leave anything out of notes?

Yes. You did a fantastic job. Maybe I'll just add a few key points that NeuroSeq is really addressing a large and expanding market, and so it's benefiting from that market, and as Mary Ann shared, The adoption of the Alzheimer's DMTs is critical, but also the other point to add in is that the guidelines favor earlier diagnostic usage. So that's an important component. And then finally, I'll just kind of anchor down on the ability for us to work with our nuclear medicine customers from a Lantheus portfolio perspective is really advantageous for us and for our customers. So I would just like to add that.

Ladies and gentlemen, there are no further questions at this time. Thank you for participating in today's conference. This concludes the program. You may disconnect and have a wonderful day.